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INFANRIX® hexa
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Inactivated Poliovirus and
Haemophilus influenzae type b Vaccine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the
common questions about INFANRIX
hexa vaccine. It does not contain all
the available information. It does not
take the place of talking to your
doctor, nurse or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of your
child having INFANRIX hexa
against the expected benefits.
If you have any concerns about
your child receiving INFANRIX
hexa talk to your doctor, nurse or
pharmacist.
Keep this leaflet with this vaccine.
You may need to read it again.
What INFANRIX hexa
is used for
INFANRIX hexa is a vaccine used to
prevent six diseases: diphtheria,
tetanus, pertussis (whooping cough),
hepatitis B, poliomyelitis (polio) and
Haemophilus influenzae type b (Hib).
The vaccine works by causing the
body to produce its own protection
(antibodies) against these diseases.
Diphtheria, tetanus, pertussis and Hib
are all serious life-threatening
diseases caused by bacterial
infection. Hepatitis B and
poliomyelitis are infectious diseases
caused by viral infection.
Diphtheria
Diphtheria mainly affects the airways
and sometimes the skin. Generally
INFANRIX® hexa
the airways become inflamed
(swollen) causing severe breathing
difficulties and sometimes
suffocation. The bacteria also release
a toxin (poison), which can cause
nerve damage, heart problems, and
death. The risk of serious
complications and death is greater in
the very young and elderly.
Tetanus (Lockjaw)
Tetanus bacteria enter the body
through wounded skin. Wounds that
are especially prone to infection are
burns, fractures, deep wounds or
wounds contaminated with soil, dust,
horse manure or wood splinters. The
bacteria release a toxin (poison),
which can cause muscle stiffness,
painful muscle spasms, fits and
death. The spasms can be strong
enough to cause bone fractures of the
spine. The death rate is 10% of
cases.
Pertussis (Whooping cough)
Pertussis is a highly infectious
illness. The disease affects the
breathing tract causing severe spells
of coughing that may interfere with
normal breathing. The coughing is
often accompanied by a ‘whooping’
sound. The cough may last for 1-2
months or longer. Pertussis can also
cause inner ear infections, longlasting bronchitis, pneumonia, fits,
brain damage and death. The risk of
severe complications and death is
greatest in infants under 6 months of
age. The death rate is 0.5% for
infants under 6 months of age.
Hepatitis B
Hepatitis B is caused by the hepatitis
B virus. It causes the liver to be
become swollen (inflamed). The
virus is found in body fluids such as
blood, semen, vaginal secretions, or
saliva of infected people. The virus
can enter the bloodstream through:
 an infected mother passing the
virus onto her baby during or
shortly after birth
 sores, cuts or tiny wounds coming
into contact with infected fluids
(eg from a human bite, sharing
razors or toothbrushes, or
working with human blood or
body fluids)
 injection (eg needlestick injury,
or sharing needles for IV drug
use)
 sexual intercourse
Some people infected with hepatitis
B may not look or feel sick. But
others will get symptoms, which may
not be seen for 6 weeks to 6 months
after infection. Sometimes people
will only have mild flu-like
symptoms, but other people can
become very ill. They may be
extremely tired, and have dark urine,
pale faeces, yellowish skin and/or
eyes (jaundice), and other symptoms
possibly requiring hospitalisation.
Most adults fully recover from the
disease. However, some people,
particularly children, who may not
have had symptoms, can remain
infected. They are called hepatitis B
virus carriers. Hepatitis B carriers
can infect others throughout their
lives.
Babies infected with hepatitis B at
birth almost always become carriers.
Often they do not show symptoms,
and seem healthy for many years.
However, after 30, 40 or 50 years
they can become sick and develop
symptoms. For all chronic hepatitis
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B carriers there is a risk of serious
liver disease, such as cirrhosis (liver
scarring) and liver cancer.
Before INFANRIX hexa
is given
Before you are given it
There is no specific treatment for
hepatitis B.
When you must not be given
it
 your child has any medical
problems such as:
Poliomyelitis (Polio)
INFANRIX hexa should not be
given if:
Polio is a viral infection that can
have variable effects. Often it causes
only a mild illness but in some
people it causes permanent injury or
death.
In its severest form, polio infection
causes paralysis of the muscles,
including those needed for breathing
and walking. Polio infection can
leave a person unable to breathe
without the help of an iron lung
machine, unable to walk without leg
braces, or confined to a wheel chair.
The limbs affected by the disease
may be painfully deformed.
Haemophilus influenzae type b
(Hib)
Hib most frequently causes brain
inflammation (swelling), which is
generally seen in infants under 18
months of age. The death rate is 510% of infants in this age group. In
15-30% of surviving infants there
will be some type of serious
complication such as: mental
retardation, cerebral palsy, deafness,
epilepsy or partial blindness. Hib
also causes inflammation of the
throat, which is mostly seen in
children over 18 months of age. It
occasionally causes death by
suffocation. Less commonly, the
bacteria can also infect the blood,
heart, lungs, bones, joints, and tissues
of the eyes and mouth.
Vaccination is the best way to protect
against these diseases. INFANRIX
hexa vaccine cannot give your child
diphtheria, tetanus, pertussis,
hepatitis B or polio infection. The
vaccine will not protect against
diseases caused by other types of
bacteria, viruses or organisms. If a
person is already infected with the
hepatitis B virus at the time of
vaccination, INFANRIX hexa may
not prevent the disease in these
people.
INFANRIX® hexa
 your child has had an allergic
reaction to INFANRIX hexa, or
any ingredient contained in this
vaccine. The ingredients in
INFANRIX hexa are listed at the
end of this leaflet. Signs of an
allergic reaction may include
itchy skin rash, shortness of
breath and swelling of the face or
tongue.
If your child had INFANRIX
hexa before and became unwell,
tell your doctor, nurse or
pharmacist before the next dose is
given.
 your child experienced a disease
of the brain within 7 days after
previous vaccination with a
pertussis containing vaccine.
 your child has had an allergic
reaction to any other diphtheria,
tetanus, hepatitis B, inactivated
polio or Haemophilus influenzae
type b vaccine (such as
ENGERIX-B®, H-B-Vax II™,
INFANRIX®, Triple Antigen™,
Tripacel™ or IPOL™ vaccine,
HIBERIX®).
 your child has a severe infection
with a high temperature. A minor
infection such as a cold should
not be a problem, but talk to your
doctor or nurse about this before
vaccination.
 the expiry date printed on the
pack has passed.
Before INFANRIX hexa is given
tell your doctor or nurse if:
 brain disease or central
nervous system (CNS) disease
(ie. epilepsy etc.)
 a bleeding problem or bruises
easily
 lowered immunity due to
medical treatment or a
medical condition
 a tendency to febrile
convulsions (seizures/fits due
to a fever or high body
temperature)
 a family history of
seizures/fits
 a family history of Sudden
Infant Death Syndrome
(SIDS)
 allergy to the antibiotics:
neomycin and polymyxin.
 after having INFANRIX hexa or
another pertussis-containing
vaccine your child had any
problems, especially:
 a high temperature (over
40.0C) within 48 hours of
vaccination
 a collapse or shock-like state
within 48 hours of vaccination
 crying lasting 3 hours or more
within 48 hours of vaccination
 convulsions (seizures/fits)
with or without a fever within
3 days of vaccination
 the packaging is torn or shows
signs of tampering.
 your child has allergies to any
other medicines or substances,
such as dyes, foods or
preservatives
If you are not sure whether your
child should have INFANRIX hexa
vaccine, talk to your doctor or
nurse. Do not give this vaccine to
anyone else; your doctor has
prescribed it specifically for your
child.
 your child has received another
vaccine recently, or is having any
prescription or OTC (over-thecounter) medicines. In particular,
mention if your child is being
given medicines which suppress
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the immune system, such as highdose steroids
Some vaccines may be affected by
other vaccines or medicines. Your
doctor, nurse or pharmacist will be
able to tell you what to do if
INFANRIX hexa is to be given with
another vaccine or medicine.
Fainting can occur following, or even
before, any needle injection,
therefore tell the doctor or nurse if
your child fainted with a previous
injection.
Higher incidence of fever (>39.5°C)
was reported in infants receiving
INFANRIX hexa and Prevenar
compared to infants receiving
INFANRIX hexa alone.
Increased reporting rates of fits (with
or without fever) and collapse or
shock-like state were observed in
infants receiving INFANRIX hexa
and Prevenar at the same visit
compared to infants receiving
INFANRIX hexa alone.
How INFANRIX hexa is
given
The doctor or nurse will give
INFANRIX hexa as an injection.
If you have any concerns about
how this vaccine is to be given, talk
to your doctor, nurse or
pharmacist.
How much is given
The dose of INFANRIX hexa is 0.5
mL.
How it is given
INFANRIX hexa will be injected
into the upper leg muscle in infants
under 12 months of age. In children
over 12 months of age, INFANRIX
hexa will usually be injected into the
upper arm muscle.
The vaccine should never be
injected into a vein, artery or the
skin.
When it is given
INFANRIX hexa is usually given as
a total of three doses as follows:
INFANRIX® hexa
First dose:
Second dose:
Third dose:
2 months of age
4 months of age
6 months of age
Each dose is given on a separate
visit. INFANRIX hexa should not be
given at birth.
chance of your child having a
permanent injury from the natural
infections.
Ask your doctor, nurse or
pharmacist to answer any
questions you may have.
You should discuss with your doctor
what is needed for your child.
Most unwanted effects with
INFANRIX hexa are mild and
usually clear up within a few days.
These effects, as with other vaccines,
generally occur around the injection
site. Side effects are more likely to
occur with booster dosing.
If a dose is missed
COMMON EFFECTS
If your child misses a scheduled
dose, talk to your doctor or nurse and
arrange another visit as soon as
possible.
Tell your doctor if your child has
any of the following that are
troublesome or ongoing:
It is important to return at the
recommended times for follow-up
doses.
 pain, redness, swelling, a hard
lump, bruising or itching around
the injection site
While INFANRIX hexa
is given
Keep your child’s follow-up visits
with the doctor or clinic. It is
important the follow-up doses of
INFANRIX hexa are given at the
correct times. This will ensure the
best effect of the vaccine in
protecting your child against
diphtheria, tetanus, pertussis,
hepatitis B, poliovirus infection and
Haemophilus influenzae type b.
Side effects
Tell your doctor or nurse as soon
as possible if your child does not
feel or look well during or after
having had a dose of INFANRIX
hexa vaccine.
INFANRIX hexa helps protect most
children from diphtheria, tetanus,
pertussis, hepatitis B, poliovirus
infection and Haemophilus
influenzae type b, but it may have
unwanted side effects in a few
children. All medicines and vaccines
can have side effects. Sometimes
they are serious; most of the time
they are not. Some side effects may
need medical treatment. The chance
of your child having a serious side
effect is very much less than the
 fever between 38C and 39.5C
 unusual crying (for more than 1
hour), vomiting, diarrhoea, runny
nose or loss of appetite
 sleepiness, nervousness,
irritability restlessness, fussiness
or difficulty sleeping
 upper respiratory tract infection,
bronchitis, runny or blocked nose
 skin rash, bruising, or purple or
red-brown spots visible through
the skin (purpura)
MORE SERIOUS EFFECTS
Tell your doctor immediately if
you notice any of the following:
 fever greater than 39.5C
 crying for 3 hours or more
 collapse, or periods of
unconsciousness or lack of
awareness
 seizures (convulsions) or fits
 your child has breathing
difficulties, please contact your
doctor. This may be more
common in the first three days
following vaccination if your
child is born prematurely (before
or at 28 weeks of pregnancy).
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Contact your doctor immediately
or take your child to the casualty
department of your nearest
hospital if any of the following
happens:
 swelling of limbs, face, eyes,
inside of nose, mouth or throat
 shortness of breath, breathing or
swallowing difficulties
 hives, itching (especially of the
hands or feet), reddening of skin
(especially around the ears), or
severe skin reactions
 unusual tiredness or weakness
that is sudden and severe
 sudden drop in blood pressure
and loss of consciousness
These are signs of an allergic
reaction. As with all vaccines given
by injection there is a very small risk
of such reactions. Allergy to
INFANRIX hexa vaccine is rare.
Any such severe reactions will
usually occur within the first few
hours of vaccination.
Other events reported after
INFANRIX vaccination, but not be
necessarily related to the vaccine
include:
 respiratory infections or
bronchitis
Other side effects not listed above,
can also occur during or soon after a
dose of INFANRIX hexa.
Check with your doctor or nurse if
your child has any other effects.
Do not be alarmed by this list of
possible side effects. Your child may
not experience any of them.
After being given
INFANRIX hexa
Storage
INFANRIX hexa vaccine is usually
stored at the doctor’s clinic or
surgery, or at the pharmacy. But if
you need to store INFANRIX hexa
always:
INFANRIX® hexa
 Keep INFANRIX hexa in the
refrigerator stored between +2C
and +8C.
THE PACK SHOULD NEVER
BE FROZEN. FREEZING
DESTROYS THE VACCINE.
 Keep the vaccine out of the reach
of children.
 INFANRIX hexa should not be
used 8 hours after opening.
 Keep INFANRIX hexa in the
original pack until it is time for it
to be given.
Disposal
Ask your pharmacist what to do
with any left over INFANRIX hexa
vaccine that has expired or has not
been used.
Product description
What it looks like
INFANRIX hexa comes in two parts.
The first part is a white, milky liquid
(0.5 mL) in a pre-filled syringe that
consists of the combined diphtheria,
tetanus, pertussis, hepatitis B and
inactivated poliovirus vaccine. The
second part is the Hib vaccine and is
a white pellet in a separate glass vial.
These parts are mixed together
before use.
When both parts are mixed the
vaccine looks like a white,
cloudy/milky liquid.
Ingredients
The active ingredients of INFANRIX
hexa are non-infectious substances
from tetanus, diphtheria bacteria,
purified proteins of pertussis
bacteria, the surface protein of the
hepatitis B virus (HBsAg, derived
from genetically engineered yeast
cells) and inactivated poliovirus.
The vaccine cannot cause these
diseases.
Each 0.5 mL dose contains:
 ≥30 IU (25 LfU) of diphtheria
toxoid
 40 IU (10 Lf U) of tetanus
toxoid
 25 g of pertussis toxoid, 25 g
of filamentous haemagglutinin
and 8 g of pertactin
 10 g of recombinant HBsAg
protein.
 40 D-antigen units of poliovirus
Type 1, 8 D-antigen units of
poliovirus Type 2 and 32 Dantigen units of poliovirus Type 3
 10 g of purified capsular
polysaccharide of Hib covalently
bound to approximately 20-40 g
of tetanus toxoid.
The inactive ingredients in the
vaccine are: aluminium hydroxide,
aluminium phosphate, lactose,
Medium 199, neomycin (traces),
polymyxin (traces), polysorbate 80,
polysorbate 20, sodium chloride
(salt) and water.
The manufacture of this product
includes exposure to bovine derived
materials. No evidence exists that
any case of vCJD (considered to be
the human form of bovine
spongiform encephalopathy) has
resulted from the administration of
any vaccine product.
Further Information
INFANRIX hexa is only available if
prescribed by a doctor.
INFANRIX hexa comes in two parts;
a pre-filled syringe containing the
combined DTPa, hepatitis B and
polio vaccine and a separate glass
vial containing the Hib vaccine
(AUST R 132881).
Manufacturer
GlaxoSmithKline Biologicals
Rue de l'Institut 89
1330 Rixensart, Belgium.
Distributed in Australia by:
GlaxoSmithKline Australia Pty. Ltd.
Level 4,
436 Johnston Street,
Abbotsford, Victoria, 3067
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Date of Preparation:
4 July 2014
Version 4.0
INFANRIX® hexa
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